Unique ID issued by UMIN | UMIN000003799 |
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Receipt number | R000004593 |
Scientific Title | Effect of recombinant thrombomodulin (ART123) for sepsis with disseminated intravascular coagulation |
Date of disclosure of the study information | 2010/07/01 |
Last modified on | 2017/05/03 09:23:59 |
Effect of recombinant thrombomodulin (ART123) for sepsis with disseminated intravascular coagulation
Effect of rTM for sepsis with DIC
Effect of recombinant thrombomodulin (ART123) for sepsis with disseminated intravascular coagulation
Effect of rTM for sepsis with DIC
Japan |
severe sepsis, septic shock, sepsis with disseminated intravascular coagulation
Infectious disease | Emergency medicine | Intensive care medicine |
Adult |
Others
NO
Previous studies showed that recombinant thrombomodulin(rTM) may improve the outcome of sepsis induced multiple organ failure because of its anticoagulant and anti-inflammatory properties. We have performed a randomized controlled trial to assess whether rTM has the effect for sepsis induced multiple organ failure.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
28-day mortality
hemorrhagic event
28-day ICU mortality
SOFA score
data of coagulation (platelet, PT-INR, fibrinogen, FDP, TAT, PIC, ATIII, protein C, protein S)
data of inflammation (CRP, procalcitonin, IL-1beta, IL-6, TNF-alfa, HMGB1)
resolution rate of JAAM DIC score
weaning rate of mechanical ventilator
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Placebo
NO
Numbered container method
2
Treatment
Medicine |
administration of recombinant thrombomodulin
administration of saline
18 | years-old | <= |
Not applicable |
Male and Female
svere sepsis and septic shock with acute DIC score more than 4 points
hemorrhagic complication
pregnant
80
1st name | |
Middle name | |
Last name | Yasuhiro OTOMO |
Tokyo Medical and Dental University Medical Hospital
Shock, Trauma, and Critical Care Center
1-5-45 Yushima, Bunkyo-ku, Tokyo
03-5803-5102
otomo.accm@tmd.ac.jp
1st name | |
Middle name | |
Last name | Toshiki SERA |
Tokyo Medical and Dental University Medical Hospital
Shock, Trauma, and Critical Care Center
1-5-45Yushima, Bunkyo-ku, Tokyo
03-5803-5102
http://www.tmd.ac.jp/med/accm/
seraaccm@tmd.ac.jp
Tokyo Medical and Dental University Medical Hospital
Tokyo Medical and Dental University
Self funding
Japan
NO
東京医科歯科大学医学部附属病院(東京都)
2010 | Year | 07 | Month | 01 | Day |
http://www.tmd.ac.jp/med/accm/
Partially published
http://www.tmd.ac.jp/med/accm/
As of December 30, 2014, there were 27 cases for intervention group and 28 cases for placebo group.
Completed
2008 | Year | 10 | Month | 01 | Day |
2010 | Year | 07 | Month | 01 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
One adverse event occurred among intervention group.
2010 | Year | 06 | Month | 22 | Day |
2017 | Year | 05 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004593
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